Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in H. Pylori Eradication

14-day Banxiaxiexin Decoction Combined With Vonoprazan-Amoxicillin Dual Therapy in the Treatment of Helicobacter Pylori Infection Complicated With Functional Dyspepsia:A Single-Center,Randomized Controlled Study

Vonoprazan and high-dose amoxicillin dual therapy was used as a control group to evaluate the clinical efficiency and safety of Banxiaxiexin decoction combined with vonoprazan and high-dose amoxicillin dual therapy in the treatment of helicobacter pylori infection complicated with functional dyspepsia,through a randomized controlled trail.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Vonoprazan; Drug: Amoxicillin; Drug: Banxiaxiexin decoction

Detailed Description

Helicobacter pylori（H.pylori）is a gastric pathogen, related to various gastrointestinal disorders. It's now a consensus of experts that H.pylori infection should be treated once it is recognized. Vonoprazan and high-dose amoxicillin dual therapy is a potential H.pylori eradication regimen. It provides a satisfactory eradication rate of 90%. Nevertheless,it has certain limitations, including a series of problems such as low eradication rate and more side effects of eradication in recurrent patients. The main side effects of the dual therapy for eradication are related symptoms of gastric motility deficiency and indigestion, such as bloating, abdominal pain, belching, acid reflux, etc. Combining traditional Chinese medicine may be one of the effective ways to solve the above problems.This study aims to compare the efficacy of Banxiaxiexin decoction combined with vonoprazan and high-dose amoxicillin dual therapy,with that of vonoprazan and high-dose amoxicillin dual therapy.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Nanjing First Hospitai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-65 years old
2. Patients with H.pylori infection
3. Diagnosed as functional dyspepsia
4. Meet the diagnostic criteria of H. pylori cold-heat syndrome in traditional Chinese medicine.
5. Patients who have not received H. pylori eradication treatment before, or who have failed eradication in the early stage but have not received eradication treatment within six months.
6. Volunteer to participate in this experiment and sign the informed consent.

Exclusion Criteria:

1. Allergy to research drugs (penicillin allergy, etc.)
2. Patients with gastric and duodenal ulcer, pyloric obstruction, esophageal and gastric varices, gastrorrhagia, gastrointestinal mucosa with dysplasia, gastric malignant tumor and other gastrointestinal diseases.
3. Patients with severe heart, brain, liver, kidney, hematopoietic system and connective tissue diseases
4. Patients who have received H. pylori eradication treatment within six months.
5. Antibiotics and bismuth were used 4 weeks before the start of study treatment, and histamine H2 receptor antagonist or PPI was used 2 weeks before the start of study treatment.
6. Use adrenocortical hormone, non-steroidal anti-inflammatory drugs or anticoagulants.
7. History of esophageal or gastric surgery
8. Pregnant and lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vonoprazan-amoxicillin dual therapy; Participants received Vonoprazan 20 mg tablet orally twice daily and Amoxicillin 1 g tablet orally three times daily for 2 weeks.	Drug: Vonoprazan; 20 mg tablet twice daily; Other Names: Vonoprazan fumarate; Drug: Amoxicillin; 1 g tablet three times daily; Other Names: Amoxicillin Capsules
Experimental: Banxiaxiexin decoction combined with vonoprazan-amoxicillin dual therapy; Participants received Vonoprazan 20 mg tablet orally twice daily,Amoxicillin 1 g tablet and Banxiaxiexin decoction 100 ml liquid-medicine orally three times daily for 2 weeks.	Drug: Vonoprazan; 20 mg tablet twice daily; Other Names: Vonoprazan fumarate; Drug: Amoxicillin; 1 g tablet three times daily; Other Names: Amoxicillin Capsules; Drug: Banxiaxiexin decoction; 100 ml liquid-medicine twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Helicobacter pylori eradication rate	Eradication of H. pylori is assessed by a 13C-urea breath test (13C-UBT) performed 4 weeks after completion of eradication therapy (at week 6). A negative 13C-UBT result indicates successful eradication.	At 4 weeks post-treatment (week 6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspeptic symptom score	Dyspeptic symptoms (epigastric pain, epigastric burning, postprandial fullness, early satiation) are assessed using a 4-point Likert scale for both frequency and severity. Frequency is graded as 0 (none), 1 (1-2 days/week for pain/burning; 3 days/week for fullness/satiation), 2 (3-4 days/week for pain/burning; 4-5 days/week for fullness/satiation), or 3 (≥5 days/week for pain/burning; 6-7 days/week for fullness/satiation). Severity is graded as 0 (none), 1 (mild, does not affect daily activities), 2 (moderate, can be tolerated but partially affects daily activities), or 3 (severe, difficult to tolerate and significantly affects daily activities). The total symptom score is calculated as the sum of (frequency score × severity score) for each symptom, with a possible range from 0 to 36. Higher scores indicate worse dyspeptic symptoms.	Baseline (week 0), immediately after 2-week treatment (week 2), and at follow-up (week 6)
Incidence of adverse events	Adverse events occurring during the treatment period are recorded via telephone follow-up. The incidence and type of adverse events are documented.	During the 2-week treatment period (days 1-14)
Medication adherence rate	Medication adherence is evaluated using the medication possession ratio (MPR). MPR is calculated as (actual number of doses taken / expected number of doses) × 100%. Good adherence is defined as MPR ≥80%; poor adherence as MPR <80%.	During the 2-week treatment period (days 1-14)
Tongue coating microbiota composition	Tongue coating samples are collected at baseline (week 0), after 2-week treatment (week 2), and at follow-up (week 6). Samples are obtained by swabbing a 2 cm × 2 cm area on the dorsal tongue surface with a sterile cotton swab after rinsing with saline. Samples are stored at -80 °C for subsequent 16S rRNA sequencing to analyze changes in microbiota composition and diversity.	Baseline (week 0), week 2, and week 6

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Chair: Wanli Liu, Doctorate, Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Actual): November 30, 2024
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 14, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Helicobacter Infections; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amides; Penicillin G; beta-Lactams; Lactams; Ampicillin; Penicillins; Amoxicillin; 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
• Other Study ID Numbers: KY20240123-08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No